Principal Medical Writer

🔥 20 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Research, develop, write, and edit high-quality clinical and regulatory documents • Lead complex medical writing projects, ensuring scientific accuracy, regulatory compliance, and timely delivery • Prepare Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Informed Consent Forms (ICFs) • Serve as a lead medical writer, submission coordinator, and primary client contact as appropriate • Coordinate contributions from multiple writers and cross-functional stakeholders • Manage project priorities, timelines, and deliverables while maintaining high-quality standards • Develop trusted relationships with clients and internal partners • Collaborate with stakeholders to align expectations, resources, and project objectives • Provide medical writing expertise to support proposals and new business opportunities • Mentor, train, and share knowledge with colleagues • Identify opportunities to improve medical writing processes, efficiency, and quality • Contribute to collaboration, continuous learning, and innovation across the Medical Writing organization

🎯 Requirements

• Bachelor's degree in Life Sciences, Health Sciences, or a related discipline, or equivalent qualifications • Strong understanding of clinical research, drug development, and applicable regulatory guidelines • Extensive experience preparing clinical and regulatory documentation, particularly CSRs, IBs, and ICFs • Demonstrated experience managing complex medical writing projects • Knowledge of resource planning and productivity management • Advanced proficiency in Microsoft Word • Familiarity with document management systems, SharePoint, Excel, and related technologies • Fluency in written and spoken English • Exceptional written, verbal, interpersonal, and negotiation skills • Ability to work in a global, matrixed environment with diverse teams and stakeholders • Strong attention to detail and ability to balance multiple projects and competing priorities

🏖️ Benefits

• Fully remote work from Canada • Opportunity to contribute to clinical research that helps bring innovative treatments to patients worldwide • Lead complex medical writing projects and play a key role in regulatory documentation and submissions • Collaborate with talented medical writers, cross-functional teams, and clients across the life sciences industry • Mentor colleagues and contribute to continuous improvement • Meaningful global clinical development initiatives

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